3D Systems Supports First FDA-Cleared Point-of-Care Implant

3D Systems revealed its role in allowing the Defense Health Agency (DHA) and the Walter Reed National Military Medical Center’s 3D Medical Applications Center (3D MAC) to receive U.S. Food and Drug Administration (FDA) clearance for the 3D MAC titanium cranial plate (TCP) system.

According to the company, the 3D MAC TCP system is the first FDA-cleared implant awarded to a point-of-care institution. 3D MAC’s patient-specific Titanium Cranial Plate (TCP) will be used to treat U.S. active duty personnel and war fighters suffering from traumatic head injuries.

The milestone culminates a multiyear collaboration between 3D Systems and 3D MAC to advance clinical additive manufacturing. Based at Walter Reed National Military Medical Center, 3D MAC develops patient-specific anatomical models, surgical guides and implants for service members and veterans.

3D Systems provided expertise in process controls, device design, additive manufacturing, and regulatory strategy, helping 3D MAC move from concept to an FDA-cleared, point-of-care-manufactured implant.

The clearance marks the first FDA-cleared implant granted to a point-of-care institution and 3D MAC’s first FDA-cleared medical device. It also highlights 3D Systems’ role in helping healthcare institutions advance point-of-care manufacturing from concept through regulatory clearance and commercialization.

3D Systems worked closely with 3D MAC to establish a robust quality management system (QMS) and provided support across the full development lifecycle, from design and validation through regulatory submission.

Earlier this year, the company earned FDA clearance for expanded indications to its VSP Orthopedics virtual surgical planning and patient-specific instrumentation platform. The planning tool now includes skeletally mature adolescents of normal bone stature, besides adults.

Comments from 3D Systems execs

Jeff Graves, president and CEO: “We believe point-of-care manufacturing is transforming the future of healthcare by bringing personalized medical devices closer to the patient. Our unique collaborations with the U.S. Defense Health Agency and the Department of Veterans Affairs underscore our leadership in this space and reinforce our commitment to expanding this business as a long-term growth driver for 3D Systems.”

Natalie Byrnes, manager of product development, patient specific medical technology: “This clearance underscores the power of combining clinical innovation with deep expertise in additive manufacturing and regulatory compliance. We are honored to help enable expanded access to personalized care delivered at the point of treatment.”